Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling the Peaks
(Stocks hitting 52-week highs on Sept. 5)
- Aptinyx Inc (NASDAQ: APTX)
- Avanos Medical Inc (NYSE: AVNS)
- BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX)
- Inspire Medical Systems Inc (NYSE: INSP)
- CareDx Inc (NASDAQ: CDNA)
- ProQR Therapeutics NV (NASDAQ: PRQR)
- Repligen Corporation (NASDAQ: RGEN)
- Tricida Inc (NASDAQ: TCDA)
- Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)
Down In The Dumps
(Stocks hitting 52-week lows on Sept. 5)
- Histogenics Corp (NASDAQ: HSGX)
- Oncolytics Biotech, Inc. (USA) (NASDAQ: ONCY)
- Pernix Therapeutics Holdings Inc (NASDAQ: PTX)
Stocks In Focus
Spectrum Pharma Reports Robust Data For Lung Cancer Drug
Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) released online abstract containing new interim poziotinib Phase 2 data from the MD Anderson Phase 2 non-small cell lung cancer study. The interim results, which included data from the EGFR cohort, and the HER2 cohort, collected through May 3, showed robust efficacy with an objective response rate, or ORR, pf 58 percent in heavily pre-treated population.
Median progressive-free survival was 5.6 months, with the disease control rate at 90 percent. In the HER2 cohort the ORR was 50 percent, and the disease control rate was 83 percent.
The company said it will present updated data in an oral session at the IASLC 19th World Conference on Lung Cancer on Sep. 24.
Shares rose 4.75 percent to $22.05 in after-hours trading.
Misonix Q4 Loss Widens
Misonix, Inc. (NASDAQ: MSON) reported fiscal-year fourth-quarter revenues of $8.6 million, higher than $7.6 million last year. The company's net loss widened from $0.4 million in Q4'17 to $1.8 million in Q4'18.
The stock fell 0.8 percent to $18.05 in after-hours trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For These September PDUFA Dates
Dicerna To Offer Common Shares
Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) commenced a proposed underwritten registered public offering of 6.15 million shares. The company said it intends to use the net proceeds for preclinical studies and clinical trials, continued technology platform development and working capital & general corporate purposes.
The stock slid 4.72 percent to $15.15 in after-hours trading.
ProQR Therapeutics To Offer $75 Million Worth of Shares
ProQR, which more than doubled Wednesday in reaction to the release of clinical trial data, said it intends to offer and sell $75 million worth of its ordinary shares in an underwritten public offering. All the shares earmarked for the offering are sold by the company.
The stock plunged 12.82 percent to $15.30 in after-hours trading.
Novartis to Divest U.S. Dermatology & Generic U.S. Oral Solids Portfolio
Novartis AG (ADR) (NYSE: NVS) announced an agreement to sell selected portions of Sandoz U.S. portfolio, specifically the Sandoz U.S. dermatology business and generic U.S. oral solids portfolio to Aurobindo Pharma's U.S. subsidiary for $0.9 billion cash and $0.1 billion in potential earn-outs.
"This transaction supports the Sandoz strategy of focusing on complex generics, value-added medicines and biosimilars to achieve sustainable and profitable growth in the US over the long-term," Novartis said.
Gilead, Galapagos Say Spondylitis Drug Trial Achieves Primary Endpoint
Gilead Sciences, Inc. (NASDAQ: GILD) and GALAPAGOS NV/S ADR (NASDAQ: GLPG) announced the Phase 2 TORTUGA study that evaluated filgotinib, their investigational JAK1 inhibitor, achieved its primary endpoint in adults with moderately to severely active ankylosing spondylitis.
Eyepoint's Eye Inflammation Drug to Get CMS Coverage
Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) announced that the CMS has approved transactional pass-through status and reimbursement through a C-code for Dexycu 9 percent. Dexcy is a FDA-approved product for treating post-operative inflammation, administered as a single intraocular dose at the end of the ocular surgery.
The code becomes effective Oct. 1.
Shares surged 17.45 percent to $2.49 in after-hours trading.
Novocure's Alternating Electric Field Therapy Found Effective In Mesothelioma
Novocure Ltd (NASDAQ: NVCR) said final results from its Phase 2 STELLAR trial in mesothelioma demonstrated a significant extension in median overall survival among patients treated with Tumor Treating Fields, plus standard of care chemotherapy compared to control group that received chemotherapy alone.
The stock jumped 9.86 percent to $47.35 in after-hours trading.
Retrophin Prices Upsized Debt Offering
Retrophin Inc (NASDAQ: RTRX) priced its upsized offering of $240 million aggregate amount of 2.50 percent convertible senior noted due 2025 to be sold in an underwritten offering. Earlier, the company intended to offer $200 million worth of notes.
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